Lead Core Business Support Engineer

Job Description

Summary The Lead Core Business Support Engineer will contribute to product and process change projects for existing Hollister products and processes in our Continence Care business. The projects will be primarily related to Technical Transfer, Process Change, Material Change, Supply Security (stay in business), and Cost Savings. This is a permanent position based at the Gurugram facility. The successful candidate will be capable of leading cross-functional projects to deliver solutions, will have a good understanding of medical device design and change controls, be capable of coordinating teams and interfacing with colleagues at all levels within the organization. The successful candidate is expected to help drive the development and integration of new materials, processes or technologies into new products and processes. RESPONSIBILTIES Live the Hollister Immutable principles, Develop test plans, analyze test data and interpret results. Generate original ideas based on professional knowledge of product design for both ostomy and Continence care products. Develop realistic action steps, timetables, and resource estimates for technical projects. Identifies potential challenges and proactively work to address them. Actively participate on cross-functional teams (international) and supports the completion of team deliverables. Conducting statistical analysis of data and developing detailed reports documenting results, conclusions and recommendations. Validate plans within the team and acts on suggestions for improvement. Establishes a rapport with their working teams which allows them to identify key resources and network efficiently. Supports technical management in establishing goals and strategies. Communicate effectively and review project outcomes with internal customers. Completes written reports on technical activities carried out. Prepares and updates a range of technical documents including drawings and specifications. Provides technical support to Manufacturing, Engineering, Quality and Supply Chain. Representing the Research & Development function on cross-functional teams throughout the Product Lifecycle process Apply comprehensive knowledge, independently, on concepts, principles, and technical capabilities for projects of large scope and complexity. Write and coordinate technical documentation, including protocols, reports, procedures, specifications, work instructions, and original data. Essential Functions Of The Role General office environment - position may require sitting at a desk / computer for extended periods of time . The position also will require travel to other Hollister facilities and various suppliers ( Talking, walking, vision, hearing, fine motor skills, writing, lifting up to 30 lbs.(occasionally), and pushing Some, but not all aspects of this job could be modified to accommodate the physical abilities of a handicapped person Work Experience Requirements 10 to 14 years’ experience in a similar position, preferably in the medical devices sector Proven track record in project management, coordination of teams, and people and project leadership; capable of working independently Uses problem solving techniques such as DMAIC to resolve issues as they arise Demonstrates working knowledge of standard techniques, procedures, and criteria in accomplishing well-defined tasks Strong communication skills, with ability to articulate relevant technologies and processes to others in the technical group and provide project updates to non-technical key stakeholders Solves technical issues using alternative or unique approaches Recognizes value-added product features and integrates them into product designs Demonstrates awareness of current technological trends, especially within their specific discipline Previous knowledge or experience in field of Ostomy, Continence care would be added advantage (not mandatory) Previous knowledge or experience in polymer films, bonding technology would be added advantage (not mandatory) Ability to create, read, edit, and interpret 2D and 3D drawings as well as product specifications (with minimal oversight). Educational Requirements Bachelor of Science / Engineering degree or higher preferably with Biomechanical Engineering, Mathematics or Statistics as a subject PMP Certification is desirable (not essential) Specilized Skills/ Technical Knowledge Experience with the FDA Quality Systems Regulations and an ISO 13485 environment at a medical device manufacturer (preferred) Project management training and experience (preferred) Experience with product development, design controls, change controls and risk management for medical devices. Advanced statistics training and experience with plastic proicessing and/or automated assembly processes (nice to have) LOCAL SPECIFICATIONS (Work Environment / Language) English Local Language Hybrid work environment with 3 days in the office and 2 days at home – performance based Two days per week will require flexible work hours to accommodate international project work with the USA and Europe Mode - Hybrid Location - Gurugram Show more Show less